Main findings
FIDEL is the largest randomized, double-blind, placebo-controlled,
multicentre trial conducted to date to assess the value of early and
systematic fibrinogen supplementation (3 g) in PPH patients requiring
prostaglandin administration following vaginal delivery. Despite the
large study size, we failed to demonstrate an effect of the strategy on
transfusion requirements and/or postpartum anaemia, total blood loss, or
the need for balloon tamponade or invasive haemostatic procedures. Our
study results are in agreement with those of two other recent randomized
studies: FIB-PPH, conducted in Denmark 24 and OBS2,
conducted in the United Kingdom (UK) 17. No
thromboembolic or any other relevant undesirable events were recorded in
the fibrinogen group, underlining that early administration of 3 g
fibrinogen concentrate appears safe in this context.